Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
☩Howard Morris Australia
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
☩Jill Tate Australia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

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Giuseppe Agosta

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Arianna Lucini Paioni
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Articoli con TAG: biomarcatori

Validazione di nuovi marcatori di neoplasia: la posizione ufficiale dell’“European Group on Tumor Markers”
Validation of new cancer biomarkers: a position statement from the European Group on Tumor Markers
<p>Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use. In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study. Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. With rigorous application, all stakeholders, and especially patients, would be expected to benefit.</p>
Biochimica Clinica ; 41(1) 102-113
Il meglio di Clinical Chemistry - Clinical Chemistry Highlights
Ruolo dei biomarcatori per la diagnosi precoce e il monitoraggio delle malattie neurologiche
Biochimica Clinica ; 44(2) 117-118
Editoriale - Editorial
Accuratezza dell’immunonefelometria come metodo di screening per la determinazione della proteinuria di Bence Jones
Accuracy of immunonephelometry as a screening method for Bence Jones proteinuria
<p>The Bence Jones protein (BJP) is an important biomarker for the identification and management of patients with plasma cell dyscrasia. The recommended method for BJP detection is the immunofixation, which is a time consuming and expensive procedure. The aim of the study was to evaluate immunonephelometry (INA) as a screening method for the identification of urine samples negative for BJP and to compare it to a simplified immunofixation method (uIFE-3). First morning urine samples were collected from 1000 consecutive patients and analyzed by INA. Samples with free light chain concentrations &gt;10 mg/L and &gt;5 mg/L were considered positive. All samples were further analyzed by uIFE-3 using 3 antisera (anti-GAM, -&kappa; and -&lambda;). The INA results (at both cut-off levels) were compared with the uIFE-3, showing a poor accuracy due to the high number of false positives and false negatives. Consequently, INA resulted unable to accurately screen BJP.</p>
Biochimica Clinica ; 41(2) 148-153
Contributi scientifici - Scientific papers
Copeptina e patologie cardiocerebrovascolari
Copeptine in cardiocerebrovascular disease
P. Pezzati, F. Balboni
<p>Copeptin (CP) is a 39 amino acid glycopeptide including the Cterminal&nbsp;domain of the arginine vasopressine precursor. CP is known to be a stable and sensitive surrogate marker&nbsp;for arginine-vasopressine release and it has been investigated as possible diagnostic and prognostic marker in&nbsp;cardiovascular and cerebrovascular diseases. In particular, the role of CP in the early diagnosis of acute myocardial&nbsp;infarction has been widely investigated and various systematic reviews are currently available. CP associated with&nbsp;cardiac troponin T has been reported to carry a good diagnostic accuracy. These data need, however, to be revised&nbsp;according to the introduction of highly sensitive assays for measuring troponins. Although some evidence on the&nbsp;prognostic value of CP in various cardiovascular frameworks is available, natriuretic peptides maintain a leading role.&nbsp;The research on CP is currently investigating its prognostic value in stroke and transient ischemic attack. However,&nbsp;due to the small sample size of studies and the lack of sound evidence, there are no minimal indications for&nbsp;requesting CP in this framework.</p>
Biochimica Clinica ; 39(3) 168-177
Rassegne - Reviews
Confronto tra marcatori sierici di fibrosi e biopsia epatica
A comparison between serum biomarkers of fibrosis and liver biopsy
V. Pecoraro, R.M. Russo, G. Perricone, S. Brenna, S. Granata
<p>Hepatic fibrosis is a common response to&nbsp;prolonged liver injury and the liver biopsy is the standard method for assessing it. However, searching for alternative&nbsp;noninvasive approaches is important and immunoenzymatic assays using monoclonal antibodies have been recently&nbsp;developed to investigate the diagnostic utility of serum biomarkers. In this study, we explore the relationship between&nbsp;the grade of liver fibrosis and some biochemical parameters. We considered the following markers: collagen IV (CIV),&nbsp;coliglicin (CG), hyaluronic acid (HA), laminin (LN) and aminoterminal procollagen type III peptide (PIIIP). All markers&nbsp;were analyzed by new chemiluminescence immunoassays. We enrolled 36 patients with liver disease and available&nbsp;liver biopsy data. Furthermore, we compared the serum marker concentrations of patients with those of 16 healthy&nbsp;volunteers. Results showed a significant increase in concentrations of CIV, CG and PIIIP in patients with liver fibrosis.&nbsp;For CIV and PIIIP, a significant difference was also observed among groups with different fibrosis grade. In particular,&nbsp;a significant increase was evident in patients with early fibrosis when compared to patients without fibrosis.</p>
Biochimica Clinica ; 39(3) 188-192
Contributi scientifici - Scientific Papers
Raccomandazioni italiane di consenso per una diagnosi eziologica basata sui biomarcatori in pazienti con deterioramento cognitivo lieve
Italian consensus recommendations for a biomarker-based aetiological diagnosis in mild cognitive impairment patients
<p>Background and purpose: Biomarkers support the aetiological diagnosis of neurocognitive disorders in vivo. Incomplete evidence is available to drive clinical decisions; available diagnostic algorithms are generic and not very helpful in clinical practice. The aim was to develop a biomarker-based diagnostic algorithm for mild cognitive impairment patients, leveraging on knowledge from recognized national experts.<br />Methods: With a Delphi procedure, experienced clinicians making variable use of biomarkers in clinical practice and representing five Italian scientific societies (neurology &ndash; Societa Italiana di Neurologia per le Demenze; neuroradiology &ndash; Associazione Italiana di Neuroradiologia; biochemistry &ndash; Societa Italiana di Biochimica Clinica; psychogeriatrics &ndash; Associazione Italiana di Psicogeriatria; nuclear medicine &ndash; Associazione Italiana di Medicina Nucleare) defined the theoretical framework, relevant literature, the diagnostic issues to be addressed and the diagnostic algorithm. An N&ndash;1 majority defined consensus achievement.<br />Results: The panellists chose the 2011 National Institute on Aging and Alzheimer&rsquo;s Association diagnostic criteria as the reference theoretical framework and defined the algorithm in seven Delphi rounds. The algorithm includes baseline clinical and cognitive assessment, blood examination, and magnetic resonance imaging with exclusionary and inclusionary roles; dopamine transporter single-photon emission computed tomography (if no/unclear parkinsonism) or metaiodobenzylguanidine cardiac scintigraphy for suspected dementia with Lewy bodies with clear parkinsonism [round VII, votes (yes-no-abstained):3-1-1]; 18F-fluorodeoxyglucose positron emission tomography for suspected frontotemporal lobar degeneration and low diagnostic confidence of Alzheimer&rsquo;s disease (round VII, 4-0-1); cerebrospinal fluid for suspected Alzheimer&rsquo;s disease (round IV, 4-1-0); and amyloid positron emission tomography if cerebrospinal fluid was not possible/accepted (round V, 4-1-0) or inconclusive (round VI, 5-0-0).<br />Conclusions: These consensus recommendations can guide clinicians in the biomarker-based aetiological diagnosis of mild cognitive impairment, whilst guidelines cannot be defined with evidence-to-decision procedures due to incomplete evidence.</p>
Biochimica Clinica ; 44(2) 194-205
Documenti SIBioC - SIBioC Documents
Amiloidosi AL: il cuore del problema
AL amyloidosis: the heart of the problem
M. Vidus Rosin, G. Palladini, G. Merlini
<p>Immunoglobulin light chain amyloidosis (AL) is characterized by the&nbsp;production of immunoglobulin light chains with conformational abnormalities that cause systemic toxicity with rapid&nbsp;deterioration of the function of vital organs. When the heart is involved, as it is the case in ~3/4 of patients, clinical signs&nbsp;and symptoms often appear when organ damage is already irreversible and the treatment cannot longer change the&nbsp;course of disease. Although in recent years new powerful therapeutic regimens have become available, which are able&nbsp;to significantly improve long-term survival, the mortality rate in the first year after diagnosis has indeed not improved, still&nbsp;being 25-30%. Cardiac involvement is responsible for almost all of these deaths. Early diagnosis based on biochemical&nbsp;markers of the disease rather than on clinical symptoms and signs can allow for early detection of patients with cardiac&nbsp;amyloidosis and to establish an effective therapy. To this end, our group has proposed the introduction of the&nbsp;measurement of natriuretic peptides that can identify the presence of amyloid cardiomyopathy with a sensitivity of 100%&nbsp;in the monitoring of subjects with monoclonal gammopathies of undetermined significance (MGUS) and altered ratio of&nbsp;circulating free light chains (FLC). Individuals with MGUS and altered FLC ratio are at intermediate/high risk of&nbsp;developing a malignant disease (AL amyloidosis in 10-15% of cases) and, according to the guidelines of the International&nbsp;Myeloma Working Group, they should be monitored regularly for their entire life. Here we describe a case where the&nbsp;application of these recent recommendations has allowed the timely recognition of amyloid cardiomyopathy.</p>
Biochimica Clinica ; 39(3) 220-222
Casi clinici - Case report
L’uso dei biomarcatori del liquido cerebrospinale nella diagnosi della malattia di Alzheimer: un’indagine tra i laboratori italiani
The clinical use of cerebrospinal fluid biomarkers for Alzheimer’s disease diagnosis: an Italian survey
<p>The use of cerebrospinal fluid (CSF) biomarkers amyloid <span style="font-family:symbol; font-size:12.0pt">b</span><sub>1-42</sub> (A<span style="font-family:symbol; font-size:12.0pt">b</span><sub>42</sub>), tau (T-tau), and phosphorylated tau (p-tau<sub>181</sub>) for the diagnosis of Alzheimer&rsquo;s Disease is limited to a restricted number of neurological centers. By a survey, we aimed to do a &ldquo;selfie&rdquo; of the use and diffusion of CSF biomarkers of dementia in Italy, the standardization of pre-analytical procedures, the harmonization of ranges, and the participation to Quality Control programs. The members of SIBioC and of the Piattaforma Italiana per le Malattie Neurodegenerative della Societ&agrave; Italiana di Neurologia per le Demenze (SINdem-ITALPLANED) together with other neurological clinics all over Italy have received an online questionnaire. Forty neurological centers require CSF analyses while 7/20 regions (35%) lack CSF laboratories. Standardization of pre-analytical procedures is present in 62.02% of laboratories and only 56% participate to International Quality Control Programs. There is no harmonization of the reported cut-offs. A cost-benefit analysis, with a program for standardization and harmonization should be promoted by Scientific Societies and National Health Services.</p>
Biochimica Clinica ; 42(1) 39-43
Contributi scientifici - Scientific papers
Patologie cardiovascolari e troponine cardiache: la storia di un legame indissolubile
Cardiovascular diseases and cardiac troponins: the history of a lasting connection
<p>The evolution of the biochemical diagnosis of cardiac diseases, represents a paradigm of the laboratory medicine evolution in the recent years.<br />Starting from the use of poor specific and sensitive biomarkers, the &ldquo;so-called&rdquo; cardiac enzymes (aspartate aminotransferase; lactate dehydrogenase; creatine kinase) recommended by World Health Organization for the acute myocardial infarction (AMI) diagnosis, a fundamental development in biochemical knowledge has been obtained, providing new biomarkers (CK-MB, myoglobin) for a more specific and early diagnosis according to the clinical and therapeutic needs. However, the revolutionary biochemical issue has been represented by the discovery of cardiac troponins and by the implementation of methods allowing their measurement in emergency setting in patients with acute chest pain. Cardiac troponins, are characterized by an absolute cardiac specificity and by a high sensitivity that allow to carry out a timely and safe diagnosis of AMI, being recognized as &ldquo;gold standard&rdquo; in all clinical and biochemical guidelines. In patients with acute chest pain and in ischemic clinical setting, a typical kinetic release of biomarker concentration may be suggestive of AMI even if ECG typical patterns are lacking. The actual improvement in analytical performance of troponins methods, particularly in the analytical sensitivity, allows to extend the measurement also in diagnosis of minor myocardial damage in patients suffering from different cardiac disease, to monitor the efficacy of therapy, the progression of the disease and to provide prognostic information and risk-stratification in addition to the clinical pathway.</p>
Biochimica Clinica ; 44(2) S067-S073
Opinioni - Opinions